NeuMoDx Molecular Inc: Medical Device Recall in 2023 - (Recall #: Z-2255-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100

Product Classification:

Class II

Date Initiated: May 24, 2023

Date Posted: August 9, 2023

Recall Number: Z-2255-2023

Event ID: 92615

Reason for Recall:

Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results

Status: Ongoing

Product Quantity: 20,016 cartridges

Code Information:

GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528

Distribution Pattern:

US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE

Voluntary or Mandated:

Voluntary: Firm initiated